Overview of Clinical Basics

Clinical Basics consists of two components which allow users to create and maintain clinical trials.

  • Vault Clinical Basics: eTMF is a cloud-based electronic trial master file system that enables organizations to efficiently manage their clinical trials. With full support for the latest version of the TMF Reference Model, Clinical Basics: eTMF gives sponsors and CROs real-time access to clinical documentation at every point in a trial’s set-up, execution, and archival.
  • Vault Clinical Basics: CTMS gives you the ability to track and manage your clinical trial operations end-to-end, including study management, study monitoring, and issue management.

Clinical Admin

When you launch the Clinical Basics: eTMF application, the system automatically displays the Clinical Admin window.This window includes these tabs:

  • Studies: allows creation and management of studies.
  • Quality Issues: allows management of quality issues for TMF documents.
  • Global Directory: allows management of organizations and personnel.
  • Products: allows management of available products in Vault.
  • Reports: provides a set of pre-defined reports and dashboards that end-users can view.
  • Users: allows management of access to available studies in Vault.
  • Loader: allows you to load data to your Vault or extract data from your Vault in bulk.
  • Help: allows access to Vault Basics Help.

Study Management

When you launch the Clinical Basics: CTMS application, the system automatically displays the Study Mangement window.This window includes the following tabs:

  • Study Management: provides the ability to track and manage events, milestones, metrics, performance, and compliance across a study.
  • Issues: provides the ability to capture, track, and manage observations, risk mitigation actions, protocol deviations, and follow-up items for a study.
  • Subjects: allows the ability to review subjects and corresponding enrollment status.
  • Help: allows access to Vault Basics Help.

TMF Workspace

To access the TMF workspace, select it from the Tab collections drop-down.This window includes these tabs:

  • Home: allows users to view all tasks and workflows associated with their user profile.
  • Library: allows users to create a customized view of all items in their Vault Clinical Library.
  • TMF Viewer: allows staff and inspectors to navigate the TMF in TMF RM v3.0 format.
  • Reports: allows users to view a set of pre-defined reports and dashboards. Dashboards provide an at-a-glance understanding of key report metrics.
  • TMF Archive: allows users to view a list of all documents that have been archived.
  • Help: allows access to Vault Basics Help.